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NCT02864888 Clinical Trial

Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma

Brain Stem Glioma Clinical Trial

— DBSG  

Official title:
A Controlled, Study of the Effect of Combination Antineoplaston Therapy [Atengenal (A10) and Astugenal (AS2-1)] on the QT/QTc Interval In Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02864888
Other study ID # BRI-BT-53
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 2024
Est. completion date December 2025

Study information
Verified date March 2023
Source Burzynski Research Institute
Contact Stanislaw R Burzynski, MD, PhD
Phone 713-335-5664
Email srb@burzynskiclinic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this protocol study is to investigate the effect of Antineoplaston therapy on the QT/QTc interval in study subjects age 3 to 21 years with newly-diagnosed, diffuse, intrinsic brainstem glioma. This investigation is to be conducted in parallel with a phase 3 efficacy and safety study of combination Antineoplaston therapy + radiation vs. radiation alone (BRI-BT-52).

Description:

QT/QTc interval prolongation is investigated during the first two weeks of subject participation in the parallel phase 3 study. The pre-cordial leads and lead II will be utilized to determine QT/QTc prolongation. Descriptive information is provided on changes in T and U wave morphologies. The percentage of subjects in each therapy group who have worsening of the T and U wave morphology is documented. Discrete U waves are excluded from the QT/QTc interval measurement. Except for the pre-therapy ECGs, all ECGs are performed during one ANP therapy infusion daily, that being an afternoon infusion to account for diurnal variation in the QT/QTc interval. The study subject is at rest in the supine position for 30 minutes prior to the ECG study. The baseline QTc is derived from 3 ECGs taken on day 1 during the hour preceding the first Antineoplaston therapy infusion or the first radiation session.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 21 Years
Eligibility Inclusion Criteria: - Enrolled in BRI-BT-52 Exclusion Criteria: - Not enrolled in BRI-BT-52

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiation
Children with a diffuse, intrinsic brain stem glioma will receive radiation.
Drug:
• Atengenal
Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
• Astugenal
Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Burzynski Research Institute

References & Publications (3)

Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Childs Nerv Syst. 2014 Dec;30(12):2051-61. doi: 10.1007/s00381-014-2401-z. Epub 2014 Apr 10. — View Citation

Burzynski SR, Janicki TJ, Weaver RA, Burzynski B. Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther. 2006 Mar;5(1):40-7. doi: 10.1177/1534735405285380. — View Citation

Burzynski SR. Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 5:379-390, 2007. Epub 2007 Nov

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with an Increase in the QTc interval The mean maximum increase in QTc interval, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group. 6 weeks
Secondary Number of participants with Alterations in T and U Wave Morphology Alterations in T and U wave morphology, as determined by repeated ECGs, for the Antineoplaston therapy + Radiation study group and the Radiation only study group. 6 weeks
See also
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Completed NCT00576641 - Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma Phase 1
Terminated NCT01884740 - Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22 Phase 1/Phase 2
Not yet recruiting NCT02887040 - Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma Phase 3
Recruiting NCT00840047 - Methionine PET/CT Studies In Patients With Cancer Phase 2
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Completed NCT01236560 - Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma Phase 2/Phase 3
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Completed NCT01514201 - Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas Phase 1/Phase 2
Completed NCT01502917 - Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy Phase 1

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